LZA · Class I · 21 CFR 880.6250

FDA Product Code LZA: Polymer Patient Examination Glove

Examination gloves are among the most used medical devices in healthcare settings. FDA product code LZA covers polymer patient examination gloves — including nitrile, vinyl, and other synthetic materials.

These gloves provide a protective barrier between healthcare workers and patients during examination and non-surgical procedures. Nitrile gloves are the preferred choice for latex-sensitive patients and clinicians.

LZA devices are Class I medical devices, regulated under 21 CFR 880.6250 and reviewed by the FDA General Hospital panel.

Leading manufacturers include Shen Wei (Usa), Inc., Hartalega Sdn Bhd and Hartalega NGC Sdn. Bhd..

1181
Total
1181
Cleared
118d
Avg days
1984
Since
1181 devices
361–384 of 1181
Cleared Aug 09, 2021
Edma Synthetic Nitrile Examination Gloves
K211540
Edma Group, LLC
General Hospital · 82d
Cleared Aug 06, 2021
Nitrile Patient Examination Glove
K210725
Pingan Medical Products Co., Ltd.
General Hospital · 149d
Cleared Aug 05, 2021
Disposable Medical Nitrile Examination Gloves (Non-Sterile)
K211075
Jiangsu Cherish Medical Technology Co., Ltd.
General Hospital · 115d
Cleared Aug 05, 2021
Nitrile Patient Examination Gloves
K211434
Zhangjiagang Huayuan Protective Equipment Co., Ltd.
General Hospital · 87d
Cleared Aug 05, 2021
Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)
K211608
Jiangsu Cureguard Glove Co., Ltd.
General Hospital · 72d
Cleared Aug 04, 2021
Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)
K211714
Hengchang (Dongying) Medical Technology Co., Ltd.
General Hospital · 62d
Cleared Aug 01, 2021
H2H Powder Free Examination Blue Glove
K211182
Ntl Innovation Co., Ltd.
General Hospital · 103d
Cleared Jul 30, 2021
Disposable Nitrile Medical Examination Glove
K210691
Jiangsu Cureguard Glove Co., Ltd.
General Hospital · 144d
Cleared Jul 30, 2021
Disposable Nitrile Examination Gloves
K211264
Shenzhen Shiqiao Science and Technology Co., Ltd.
General Hospital · 95d
Cleared Jul 29, 2021
Disposable Nitrile Medical Examination Glove
K211131
Siyang Threeguard Medical Supplies Co., Ltd.
General Hospital · 104d
Cleared Jul 29, 2021
Blue Nitrile Exam Gloves
K211341
Jiangxi Surefine Medical Co., Ltd.
General Hospital · 87d
Cleared Jul 28, 2021
Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors
K211455
Shen Wei (Usa), Inc.
General Hospital · 79d
Cleared Jul 23, 2021
Nitrile Patient Examination Gloves
K211012
Huayuan Medical Technology(Shangqiu) Co., Ltd.
General Hospital · 109d
Cleared Jul 22, 2021
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs
K211220
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 90d
Cleared Jul 21, 2021
Nitrile Patient Examination Glove
K210686
Yunnan Huazhiyuan Medical Technology Co., Ltd.
General Hospital · 135d
Cleared Jul 20, 2021
Disposable Nitrile Medical Examination Glove
K210684
Jiangsu Cureguard Glove Co., Ltd.
General Hospital · 134d
Cleared Jul 15, 2021
Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
K211547
Edma Group, LLC
General Hospital · 57d
Cleared Jul 12, 2021
Nitrile Patient Examination Glove
K210723
Jiangxi Zhonghong Pulin Medical Products Co., Ltd.
General Hospital · 124d
Cleared Jul 12, 2021
Nitrile Examination Gloves
K210776
5r Med Instruments (Chengdu) Co., Ltd.
General Hospital · 119d
Cleared Jul 10, 2021
Medical Nitrile Examination Gloves (Power free, Blue)
K210578
Jiangxi Hongda Medical Equipment Group , Ltd.
General Hospital · 134d
Cleared Jun 28, 2021
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
K210587
Onetexx Sdn Bhd
General Hospital · 122d
Cleared Jun 28, 2021
White Nitrile Powder Free Patient Examination Glove, Non Sterile
K210775
Onetexx Sdn Bhd
General Hospital · 105d
Cleared Jun 25, 2021
Nitrile Glove
K211252
Jiangsu Dihong Industry and Trade Co., Ltd.
General Hospital · 60d
Cleared Jun 24, 2021
Powder Free Black Nitrile Examination Glove
K201428
Vietglove Corporation
General Hospital · 391d